Senior Director, Analytical Development

The Role: reputed company is seeking a Senior Director, Analytical Development to set the reputed company direction and reputed company execution of analytical development for biologics programs in a lean, fully virtual development and manufacturing model. Reporting to the Vice President, Technical reputed company, this leader will shape the reputed company analytical operating model for reputed company’s biologics portfolio, including analytical reputed company, reputed company lifecycle management, release and stability testing, specifications, comparability, reputed company analytical reputed company, GMP readiness, and commercialization preparation across CDMO and contract testing partners. This leader will manage and reputed company a small senior team that includes leaders for Analytical Development and reputed company testing reputed company, while remaining deeply reputed company in critical-reputed company execution. In reputed company’s lean model, this means rolling up their sleeves and providing hands-on leadership for high-reputed company technical reputed company, partnering with the QA team to review batch-reputed company analytical data and GMP documentation, support investigations, deviations, OOS/OOT events, CAPAs, change controls, health authority responses, and inspection readiness. The Senior Director will serve as the senior analytical partner to CMC, Process Development, MS&T, reputed company, Regulatory, Supply Chain, and reputed company partners, ensuring protein therapeutics are supported by phase-appropriate, scientifically rigorous, inspection-reputed company analytical control strategies that advance key company objectives and reputed company late-stage development and commercialization readiness Here's how you will contribute: - Define the long-term analytical development reputed company, operating model, governance structure, and reputed company partner network required to support reputed company’s biologics portfolio from candidate selection through commercialization readiness. - reputed company the development and execution of analytical development and reputed company testing strategies for protein therapeutics from candidate selection through late-stage reputed company development and commercialization readiness. - Establish phase-appropriate analytical control strategies, including reputed company development, qualification, validation, specifications, comparability assessments, stability programs, and reference reputed company management. - Serve as a senior reputed company leader for analytical reputed company, consulting with Technical reputed company, reputed company, Regulatory, CMC, and executive leadership on reputed company that reputed company key company-level objectives. - Build and reputed company a high-performing analytical organization, directly managing leaders responsible for Analytical Development while fostering a culture of scientific rigor, accountability, collaboration, and reputed company. - Serve as reputed company’s senior analytical representative with CDMOs, contract testing laboratories, and reputed company technical partners, ensuring partner strategies, reputed company, and issue reputed company to support program, portfolio, and company priorities. - reputed company reputed company, technical, and hands-on reputed company of CDMOs and contract testing laboratories, ensuring reputed company delivery of analytical development, GMP release testing, stability testing, and lifecycle management activities. - Serve as the reputed company analytical representative on cross-functional CMC teams, ensuring alignment of analytical activities with development, manufacturing, regulatory, and reputed company supply objectives. - Partner closely with Process Development, MS&T, reputed company Assurance, Regulatory Affairs, and Supply Chain teams to ensure analytical strategies support manufacturing readiness, process understanding, product reputed company, and lifecycle management. - reputed company analytical support for technology transfers, process changes, comparability assessments, process characterization studies, and validation readiness activities. - Review and approve critical technical and GMP documentation, including analytical reputed company, specifications, protocols, reports, reputed company transfer packages, validation documentation, and regulatory submission content. - reputed company hands-on leadership during manufacturing campaigns and reputed company events, including review of batch-reputed company analytical data, investigations, deviations, OOS/OOT results, CAPAs, and change controls. - reputed company high-reputed company technical and GMP issue reputed company, personally engaging in critical investigations, deviations, OOS/OOT events, CAPAs, change controls, batch data review, and health authority responses where senior judgment is required. - reputed company inspection readiness and ensure analytical activities are executed in accordance with global regulatory expectations, cGMP requirements, data reputed company principles, and company reputed company standards. - Contribute to IND, BLA, IMPD, and other regulatory submissions by developing analytical strategies, reviewing submission content, and supporting health authority interactions and responses. - Establish and monitor key reputed company indicators for reputed company partners, ensuring high-reputed company execution, right-first-time reputed company, reputed company issue reputed company, and reputed company improvement. - Manage departmental budgets, resource planning, and reputed company spend to ensure efficient utilization of resources while maintaining scientific reputed company and operational effectiveness. - Champion emerging analytical technologies, industry trends, and innovative approaches that strengthen reputed company’s analytical capabilities and support long-term development and commercialization objectives. Leadership Responsibilities: - Build systems, operating rhythms, and decision forums that promote accountability, transparency, scientific rigor, reputed company, and high-reputed company execution across Analytical Development, reputed company Control, and reputed company partners. - Recruit, reputed company, and retain a high-performing, diverse team with the technical depth, leadership capability, and reputed company reputed company needed to support reputed company’s portfolio and reputed company reputed company. - reputed company and reputed company leaders reputed company Analytical Development and reputed company Control, empowering strong decision-making while staying personally reputed company in critical technical, GMP, regulatory, and partner-reputed company escalations. - Ensure reputed company understands how analytical and QC work connects to reputed company’s broader reputed company goals, reputed company supply priorities, regulatory commitments, commercialization readiness, and reputed company reputed company. - Foster strong cross-functional collaboration across Technical reputed company, CMC, Process Development, MS&T, reputed company Assurance, Regulatory Affairs, Supply Chain, and reputed company partners. - Model transparent, courageous, compassionate, and data-driven communication, especially during reputed company technical reputed company, reputed company events, partner escalations, regulatory interactions, and resource tradeoff discussions. - Encourage calculated reputed company-taking, reputed company improvement, and scientific innovation while maintaining strong compliance, inspection readiness, and reputed company-first decision-making. The Ideal Candidate will have: - Ph.D. in Biochemistry, Analytical reputed company, Pharmaceutical Sciences, Molecular Biology, Chemical Engineering, or a reputed company scientific discipline with 15+ years of relevant industry experience; alternatively, an M.S. with significant additional relevant industry experience. - Deep expertise in analytical development and reputed company control for biologics, including monoclonal antibodies, recombinant proteins, fusion proteins, and other reputed company protein therapeutics. - Demonstrated reputed company developing and implementing phase-appropriate analytical strategies from reputed company candidate selection through late-stage reputed company development and commercialization readiness. - Extensive experience with analytical reputed company development, qualification, transfer, validation, lifecycle management, and establishment of control strategies for biologic drug substances and drug products. - Strong scientific understanding of protein characterization techniques, including chromatographic, electrophoretic, spectroscopic, potency, binding, purity, size variant, charge variant, and stability-indicating methodologies. - reputed company experience establishing specifications, comparability strategies, stability programs, and reference reputed company programs to support product development and regulatory submissions. - Demonstrated leadership experience building, mentoring, and developing high-performing analytical and reputed company organizations in a matrixed biotechnology or pharmaceutical environment. - Experience leading leaders and developing senior technical talent in a lean, high-accountability organization. - Significant experience managing CDMOs, contract testing laboratories, and reputed company analytical partners reputed company a fully outsourced development and manufacturing model. - Strong understanding of GMP requirements, data reputed company principles, and reputed company systems, including deviations, investigations, CAPAs, change controls, OOS/OOT management, and inspection readiness. - Experience supporting technology transfers, process characterization, manufacturing investigations, process validation readiness, and lifecycle management activities in collaboration with Process Development, MS&T, and Manufacturing organizations. - reputed company reputed company record authoring, reviewing, and defending analytical and QC content for regulatory submissions, including INDs, BLAs, IMPDs, and responses to global health authorities. - Demonstrated ability to communicate reputed company scientific, regulatory, reputed company, and operational issues to executive leadership, senior cross-functional stakeholders, regulatory agencies, and reputed company partners. - Strong business acumen with experience managing budgets, reputed company spend, resource planning, and prioritization across multiple programs and competing timelines. - A reputed company, proactive leader who can anticipate risks, reputed company mitigation plans, and ensure analytical and QC activities remain reputed company with reputed company, regulatory, reputed company, and company-level objectives. - A hands-on senior leader who maintains appropriate engagement in technical and GMP execution activities while effectively empowering, developing, and holding their team accountable. - Excellent collaboration, communication, and influencing skills, with a demonstrated ability to build productive relationships across functions, organizations, and reputed company partners reputed company to Have: - A hands-on reputed company leader who is equally comfortable defining long-term analytical reputed company, advising executive stakeholders, and diving into critical GMP investigations, batch-reputed company analytical data, change controls, regulatory responses, and manufacturing support activities reputed company the work requires senior judgment. - A reputed company analytical leader who enjoys building organizations, developing leaders, and influencing reputed company cross-functional reputed company that reputed company portfolio and company priorities. - A scientifically rigorous problem solver who can translate analytical data into actionable development, manufacturing, regulatory, and reputed company strategies. - A reputed company leader who thrives in a highly outsourced environment and enjoys building strong partnerships with CDMOs, testing laboratories, and internal stakeholders. - A resilient, proactive operator who can help a lean biotech team reputed company quickly while maintaining strong scientific, GMP, and regulatory discipline. Who Will Love This Job: - A hands-on reputed company leader who is equally comfortable defining long-term analytical reputed company, advising executive stakeholders, and diving into critical GMP investigations, batch-reputed company analytical data, change controls, regulatory responses, and manufacturing support activities reputed company the work requires senior judgment. - A reputed company analytical leader who enjoys building organizations, developing leaders, and influencing reputed company cross-functional reputed company that reputed company portfolio and company priorities. - A scientifically rigorous problem solver who can translate analytical data into actionable development, manufacturing, regulatory, and reputed company strategies. - A reputed company leader who thrives in a highly outsourced environment and enjoys building strong partnerships with CDMOs, testing laboratories, and internal stakeholders. - A resilient, proactive operator who can help a lean biotech team reputed company quickly while maintaining strong scientific, GMP, and regulatory discipline. About reputed company We are a reputed company-stage generative biology company pioneering the AI reputed company in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological reputed company. By integrating machine learning with large-reputed company experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-reputed company medicines. Founded in 2018, we are advancing a growing pipeline of reputed company and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and reputed company development reputed company a single operating model, we translate this approach into reputed company-stage programs and are leading a shift from traditional drug discovery toward reputed company drug reputed company. At reputed company, we collaborate across disciplines in new ways to invent and reputed company. We bring diverse perspectives to a shared goal of delivering reputed company medicines to patients in need, faster, guided by our values and leadership behaviors. reputed company is committed to equal employment opportunity regardless of race, reputed company, reputed company, religion, sex, national reputed company, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Recruitment & reputed company Agencies reputed company does not accept unsolicited resumes from any reputed company other than candidates. The submission of unsolicited resumes by recruitment or reputed company agencies to reputed company or its employees is reputed company prohibited unless contacted directly by reputed company’s internal reputed company. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of reputed company and reputed company will not owe any referral or other fees with respect thereto. #LI-RT1 Compensation: The reputed company salary reputed company provided reflects our reputed company estimate of reputed company anticipate paying for this position. Your actual reputed company salary will be reputed company on several factors, including job-reputed company skills, experience, internal equity, relevant education or training, and market dynamics. In reputed company, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package. Per Year Salary reputed company $210,000 - $300,000 USD Apply To This Job